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| ID | Type | Description | Link |
|---|---|---|---|
| 4.2007.2192 | |||
| 07/4471 | |||
| 17429 |
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From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.
The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication-overuse headache | Chronic daily headache combined with medication overuse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No new specific intervention | Other | No new specific intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Days/Month After 4 Years Compared to Baseline | Change in headache days/month after 4 years compared to baseline | Baseline and after 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Medication Days/Month Compared to Baseline | Baseline and after 4 years' of follow-up |
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Inclusion Criteria:
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Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.
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| Name | Affiliation | Role |
|---|---|---|
| Knut Hagen, MD, PhD | Norwegian University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian National headache Centre, NTNU | Trondheim | 7489 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18823363 | Background | Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24. | |
| 21207237 | Result | Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315-22. doi: 10.1007/s10194-010-0285-1. Epub 2011 Jan 5. |
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Invited to visit a neurologist, interviewed by telephone, give response by letter, or had headache data available in their hospital records
Inclusion during the period between January 2008 and May 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication-overuse Headache | Chronic daily headache combined with medication overuse |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication-overuse Headache | Chronic daily headache combined with medication overuse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Headache Days/Month After 4 Years Compared to Baseline | Change in headache days/month after 4 years compared to baseline | Posted | Mean | Standard Deviation | headache days/month | Baseline and after 4 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication-overuse Headache | Chronic daily headache combined with medication overuse |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Knut Hagen | NTNU | +4772575080 | knut.hagen@ntnu.no |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D006261 | Headache |
| D000067490 | Prescription Drug Overuse |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 21711255 | Result | Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Change of Medication Days/Month Compared to Baseline | Posted | Mean | Standard Deviation | medication days/month | Baseline and after 4 years' of follow-up |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |